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Brief Title: Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.
Official Title: Survival and Axillary Recurrence Following Sentinel Node-positive Breast Cancer Without Completion Axillary Lymph Node Dissection - a Randomized Study of Patients With Macrometastases in the Sentinel Node
Study ID: NCT02240472
Brief Summary: Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling. The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years. This study is a prospective international randomized trial including 3500 patients. Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.
Detailed Description: Details can be found on www.senomac.se
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sygehus Sonderjylland, Aabenraa, , Denmark
Aalborg University Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Sydvestjysk Sygehus, Esbjerg, , Denmark
Sygehus Lillebaelt, Lillebaelt, , Denmark
Odense University Hospital, Odense, , Denmark
Randers Regionshospitalet, Randers, , Denmark
Regionshospitalet Viborg, Viborg, , Denmark
Athens University Hospital, Athens, , Greece
Gävle sjukhus, Gävle, , Sweden
Sahlgrenska University Hospital, Göteborg, , Sweden
Hallands sjukhus, Halmstad, , Sweden
Helsingborg lasarett, Helsingborg, , Sweden
Länssjukhuset Ryhov, Jönköping, , Sweden
Kalmar sjukhus, Kalmar, , Sweden
Blekinge sjukhuset, Karlskrona, , Sweden
Karlstad sjukhus, Karlstad, , Sweden
Central Hospital Kristianstad, Kristianstad, , Sweden
Linköping University Hospital, Linköping, , Sweden
Malmö/Lund University Hospital, Lund, , Sweden
Skaraborgs sjukhus, Skövde/Lidköping, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Southern Gerenal Hospital, Stockholm, , Sweden
St. Görans Hospital, Stockholm, , Sweden
Sundsvall länssjukhus, Sundsvall, , Sweden
Uddevalla sjukhus, Uddevalla, , Sweden
Umeå University Hospital, Umeå, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Varbergs sjukhus, Varberg, , Sweden
Västervik Hospital, Västervik, , Sweden
Västerås Central Hospital, Västerås, , Sweden
Örebro University Hospital, Örebro, , Sweden
Name: Jana de Boniface, PhD
Affiliation: Karolinska Institutet
Role: PRINCIPAL_INVESTIGATOR
Name: Jan Frisell, Professor
Affiliation: Karolinska University Hospital
Role: STUDY_CHAIR
Name: Leif Bergkvist, Professor
Affiliation: Central Hospital Västerås
Role: STUDY_CHAIR
Name: Yvette Andersson, PhD
Affiliation: Central Hospital Västerås
Role: STUDY_CHAIR
Name: Lisa Ryden, Professor
Affiliation: Lund University
Role: STUDY_CHAIR
Name: Malin Sund, Professor
Affiliation: Umeå University Hospital
Role: STUDY_CHAIR
Name: Olofsson Roger, PhD
Affiliation: Sahlgrenska University Hospital, Sweden
Role: STUDY_CHAIR
Name: Johan Ahlgren, PhD
Affiliation: Region Örebro County
Role: STUDY_CHAIR
Name: Dan Lundstedt, PhD
Affiliation: Sahlgrenska University Hospital, Sweden
Role: STUDY_CHAIR
Name: Peer Christiansen, Professor
Affiliation: Aarhus University Hospital, Denmark
Role: PRINCIPAL_INVESTIGATOR
Name: Tove Tvedskov Filtenborg, MD
Affiliation: Rigshospitalet Copenhagen, Dnmark
Role: STUDY_CHAIR
Name: Michalis Kontos, PhD
Affiliation: University of Athens
Role: STUDY_CHAIR
Name: Birgitte Offersen, Professor
Affiliation: University of Aarhus
Role: STUDY_CHAIR
Name: Thorsten Kühn, Professor
Affiliation: Klinikum Esslingen
Role: PRINCIPAL_INVESTIGATOR
Name: Toralf Reimer, Professor
Affiliation: Universität Rostock
Role: PRINCIPAL_INVESTIGATOR
Name: Oreste Gentilini
Affiliation: San Raffaele Hospital, Milano
Role: PRINCIPAL_INVESTIGATOR
Name: Roland Reitsamer
Affiliation: Universitätsklinikum Salzburg
Role: PRINCIPAL_INVESTIGATOR